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This study aims to provide National Malaria Control Programs (NMCP), international donors and other key stake holders with clear evidence on the impact and cost-effectiveness of using indoor residual spraying (IRS) with a non-pyrethroid insecticide in a high transmission area that has universal long-lasting insecticidal net (LLIN) coverage.
The district of Mopeia, in the province of Zambezia, Mozambique will be the study site. This is a high transmission area with a malaria parasite prevalence of 54% in children, The Ministry of Health distributed LLINs in Mopeia in 2014-2015.
A simplified census will take place in mid-2016 to determine the number of children five years of age and under in the district, enumerate and map the households.
From the 115 villages/bairros existent in Mopeia, 86 clusters will be selected and randomized to either receive IRS with Actellic according to President's Malaria Initiative Africa Indoor Residual Spraying Project (PMI-AIRS) standard procedures (43 clusters) or no IRS (43 clusters). From each of these clusters, a cohort of 18 children five years of age and under will be followed monthly to assess malaria incidence at the community level in the two study arms. There will be 774 children in the IRS arm and 774 children in the no-IRS arm (total cohort will be 1548). Additionally, the routine health centre reporting system will be strengthened to assess malaria incidence in children five years of age and under by passive case detection. Two cross sectional studies in April 2017 and April 2018, will assess changes in net use, health seeking behaviour and malaria prevalence at community level.
Entomological data will be collected from both IRS and control areas to assess the vector dynamics and insecticide resistance pattern of the local vector populations from each study arm. Data on the costs of the intervention as well as health-related expenditure at health system and household levels will be collected prospectively throughout the study. These costs will be determined using both health system and societal perspective.
The incidence rate in control and intervention areas will be combined with the micro-costing data to calculate the cost per case averted at community and health facility level.
These findings will be disseminated to the NMCP and international donors and stakeholders to complement the WHO guidance on combining indoor residual spraying and long-lasting insecticidal nets.
Mopeia is a district in the Zambezia Province. Mopeia borders with the district of Morrumbala to the North, the district of Chinde and the province of Sofala to the South, the districts of Nicoadala and Inhassunge in the East and the Provinces of Sofala and Tete in the West. It has an area of 7671 km2. The projected population for 2016 is 162.188 individuals with 31.927 (19.7%) under five years of age (National Institute of Statistics, Mozambique). There are three administrative posts, eleven localities and 224 villages (Bairros) and approximately 34.603 households. There are 12 health facilities (PMI-AIRS Mozambique, unpublished data). There is little socio-economic data available from Mopeia.
The malaria burden is high in Zambezia with a parasite prevalence of 54% in under-fives . The parasite prevalence in children 1-15 years of age in Mopeia is 47.8% (38.7%-57.1%) . The mean RDT positivity rate during a recent enhanced surveillance exercise at health facilities was 62.8% (range 50-72%) . The same data suggest high incidence at health facilities, showing 470 cases per 1000 children during the same period (June-Nov 2014). Mopeia recently received 175.297 LLINs in 2013 and IRS with pyrethroids in 2014 . Residents of Mopeia will receive new LLINs in early 2017.
Data from February 2015 in the neighbouring districts of Mocuba and Morrumbala show Pyrethroid resistance in the local Anopheles gambiae s.l. population . Further north, in the district of Milange, tested Anopheles gambiae s.l. remain susceptible to pyrethroids . See table 2 below for further details. Mopeia has been selected for the present study because of its high malaria transmission intensity, the presence of LLINs in the district, and the aforementioned regional indications of reduced pyrethroid susceptibility in the target vector population, and the existence of IRS infrastructure and capacity from previous campaigns.
The villages in the selected clusters will receive IRS with Actellic according to PMI-Africa IRS (AIRS) Project operating procedures  in addition to existing LLINs. Control clusters will have existing LLINs, but will not receive IRS.
In late 2017 (year two), IRS will be repeated using the same cluster distribution and insecticide. Additionally in 2017, the whole district will be subject to universal LLIN distribution.
Adherence to interventions will be confirmed with questionnaires during the monthly active cohort visits and during the cross-sectional surveys, including questions about wall replastering/painting and net usage (SSPs COST 001, 002 and 003). Additional information will be obtained through cone bioassays.
The standard of malaria care at community and health center will remain unchanged throughout the study and stock levels of malaria commodities will be ensured.
This implementation study in Mozambique will provide detailed information of the impact and cost-effectiveness of adding IRS with an extended release formulation of the organophosphate insecticide pirimiphos-methyl (Actellic®300CS) in a high transmission area with high LLIN coverage. This information will be disseminated to the NMCP as well as to local and international stakeholders and decision makers to inform policy recommendations and choices regarding the combination of vector control strategies.
A simplified census will be conducted in June-July 2016 to obtain the total number of children five years of age and under per household and village. This information will be used in order to randomly assign the village intervention status and to determine the cohorts to be followed prospectively. The total population disaggregated in under five years of age and above five in each village in the district will be used as a denominator for the passive case detection component of the study. Each house will be geopositioned during the census visit in order to assess cluster size and household grouping in order to define the cluster size, core and buffer areas. Each household will receive a unique permID.
For this cluster-randomized trial, all villages/bairros will be enumerated, 86 clusters will be chosen among the available villages/bairros after exclusion of operationally difficult and areas that cannot be matched/stratified. Villages in which the leaders refuse consent will also be excluded. The clusters will be stratified by population size and randomized with a 1:1 ratio to receive IRS or no IRS.
To determine the incidence by active case detection, a cohort of children five years of age and under will be followed monthly from the core zone of each cluster. During each visit the care taker will answer a short questionnaire regarding health, net usage and health-related expenditure. The temperature of each recruited child will be recorded and an RDT performed. If the child has a positive RDT, irrespective of accompanying clinical symptoms he/she will receive treatment according to the national guidelines.
At health facility level, a separate facility-based team will ensure the collection of the household location (village) of each malaria case to determine the incidence in the different study clusters by passive case detection. Joint work with the community health workers (Agentes Polivantes Elementares [APEs]) will also strengthen quality of their data, they will be asked to include information on the location (village) of each malaria case they diagnose/treat.
Costing data will be prospectively collected using standardized data collection tools to determine the cost of interventions (IRS and LLIN distribution) and of care-seeking.
Cross-sectional studies will be carried out at the peak of transmission season in 2017 and 2018. There is a potential for the monthly visits for active case detection to have an influence on household behavior and expenditure. Additional data on house expenditure will be collected during the cross-sectionals to assess societal costs of malaria care that is independent from study visits.
Entomological data including mosquito densities, sporozoite rates, resistance status and indoor/outdoor biting ratios will be sampled from each study arm throughout the study following standard PMI procedures.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
District of Columbia
Not yet recruiting
Published on BioPortfolio: 2016-09-22T21:08:21-0400
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